Device and method for margin marking of radiography specimens

ABSTRACT

A marking device for defining the margins and orientation of radiography specimens includes a plurality of visually distinctive markers joined by a base that holds the markers until the markers are secured to a specimen. The base serves as a holder for the individual markers as the markers are secured to a specimen with sutures or staples, at which time the markers are disconnected from the base. One or more markers may be secured to a specimen as needed to define the orientation of the specimen. By securing markers to specific locations on a specimen, a surgeon can indicate to radiologists and pathologists the specimen&#39;s orientation in the body before removal, thus aiding in future study of the specimen. Since the markers are made either wholly or partially from radiopaque material, the markers are visible when radiographed.

FIELD OF THE INVENTION

[0001] The present invention relates to devices for marking radiographyspecimens, and in particular to devices that indicate the orientation ofthe specimen in a patient's body prior to removal. The present inventionfurther relates to radiographic markers that will remain secured tospecimens during manipulations accompanying radiography and pathology.

BACKGROUND INFORMATION

[0002] Radiologists frequently use markers that absorb xrays and cast animage when placed within an xray field to convey pertinent informationon xray film. For example, right and left markers are routinely used todesignate the anatomical orientation of the patient or to identify aparticular extremity being examined. These types of markers are oftenplaced on the surface of the examination table or xray film cassettes,within the exposure field but outside the image of the patient, todefine the patient's physical orientation in relationship to the xraybeam or the film.

[0003] Markers consisting of a radiopaque body and adhesive can beattached directly to the skin of patients. These markers give theradiologist a specific target for the xray and, since the radiopaquebody will appear on radiographs later taken, help pinpoint the locationof the area in question when reading the developed film. Some markershave been developed that can be inserted into the body to mark tissuesor organs that require repeated xray monitoring. These types of markersare manufactured as staples or hooks (to attach to tissues), and evenpartial rings (to encircle grafted veins).

[0004] All of the previously described devices, while useful forspecific purposes, have not been ideal for marking specimens removedfrom patients, as the described devices fail to address circumstancesparticular to specimen removal, radiography, and pathology. Successfulremoval of tumors from a patient's body requires an accurate evaluationof the excised tissue boundaries. To ensure that the entire tumor isremoved, an adequate amount of healthy tissue surrounding the tumor isalso extracted. The success of the surgery and the patient outcome isdirectly related to resection of the entirety of the tumor with anadequate healthy tissue boundary. For example, successful removal ofbreast tumors requires an accurate evaluation of the removed tissueboundaries to see if the tumor has effected the surrounding healthytissue.

[0005] In the case of biopsies, a specimen is marked by the surgeonduring removal from the patient. This mark aids the radiographers andpathologists in identifying the orientation of the specimen as it waspresent in the patient's body. Permanent marking of the exactorientation of the specimen is critical because of themanipulations—specimens must be pressed flat to properly xray—that takeplace during radiography. Presently, a surgeon may mark a tissuespecimen by attaching sutures of various lengths, colors, or numbercombinations. The lengths, colors, or number of sutures convey to thepathologist the orientation of the gross pathology specimen in thepatient's body. Unfortunately, this process of suturing and knotting maynot be regularly performed because it is time consuming and requiresdetailed oral and/or written communications between surgeons,radiologists, and pathologists which can result in frustrations betweenthe three professionals. Additional confusion may arise due to the factthat there is no standard marking method in the medical profession,since each surgeon develops his or her own method of marking.

[0006] Some radiopaque markers have been developed to address thisproblem, but still have some shortcomings. For example, existing markerscan be attached to specimens by securing the markers with a clampingpair of pinchers, but these markers may release while the specimen isbeing radiographed and otherwise examined, and thus, the benefit islost. Also, because such existing markers have sliding components andlocking points, they tend to be thicker and larger than ideal. Sincespecimens must lay flat for proper radiography and pathology, a large,thick marker may obscure subtle pathology within the specimen. While thesimple solution to this problem would be to decrease the marker size, ifthe marker is too small, it may be virtually impossible to hold whilesecuring to a specimen. Existing devices also fail to standardize themethod of marking specimens, thereby perpetuating the confusion andmisinterpretation between the surgeon removing the specimen and thepathologist studying the specimen.

[0007] Accordingly, it is an object of the present invention to overcomethe above-described drawbacks and disadvantages of existing markers.

SUMMARY OF THE INVENTION

[0008] The present invention is directed to a device for marking themargins of radiography specimens. The device includes a base and aplurality of markers detachably connected to the base. The base allows auser to easily grip the device while securing the small individualmarkers to a specimen. The base can take many forms from which theindividual markers extend outwardly to facilitate attachment of themarkers to specimens. The markers preferably include at least oneaperture for receiving sutures, staples, or the like, which are used tosecure the markers to specimens. After a marker is secured to aspecimen, it can be broken away from the base of the device, therebyremaining secured to the specimen during radiography and pathology. Themarkers define distinctive, radiopaque marking indicia and/or shapes.The indicia (and/or the shapes of the markers themselves) are visible ina radiograph and indicate orientation of the specimen before thespecimen was removed from the body.

[0009] One advantage of the present invention is that the device maystandardize the marking system used to indicate the orientations ofspecimens, thereby eliminating confusion between the different medicalprofessionals involved in treatment. Another advantage is that thedevice may remain fixedly secured to specimens during radiographybecause the device can be attached to a specimen with a suture, staple,or like connecting means, rather than relying on any pinching orsqueezing elements that can accidentally release. Still anotheradvantage is that the base of the device itself may be configured to beeasily gripped during use, even though the markers themselves may berelatively small (so as to limit the amount of obstruction duringx-ray). Yet another advantage is that the device may be able to retainmultiple markers with various indicia, wherein one or more of themarkers may be usable for the same or multiple specimens. Additionally,the device may be readily adaptable to mark all types of specimens andorientations.

[0010] These and other features and advantages of the invention are morefully disclosed or rendered apparent from the following detaileddescription of certain preferred embodiments of the invention, that areto be considered together with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011]FIG. 1 is a rendering of a first embodiment of a device of thepresent invention for marking the margins of a specimen shown duringuse;

[0012]FIG. 2 is a side view of the margin marking device;

[0013]FIG. 2A is a front view of the margin marking device;

[0014]FIG. 2B is a back view of the margin marking device;

[0015]FIG. 2C is a perspective view of the margin marking device;

[0016]FIG. 3 is a plan view of a second embodiment of the margin markingdevice of the present invention; and

[0017]FIG. 4 is a plan view of a third embodiment of a margin markingdevice of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] The present invention overcomes many of the problems that arisewhen other radiopaque markers are used to mark radiography specimens.The advantages, and other features of the disclosed device, will becomemore readily apparent to those having ordinary skill in the pertinentart from the following detailed description of certain preferredembodiments taken in conjunction with the drawings which set forthrepresentative embodiments of the present invention and wherein likereference numerals identify similar structural elements.

[0019] In FIGS. 1, 2, and 2A-C, numeral 110 generally refers to a marginmarking device. In FIG. 1, a marker 116 is being secured to a specimen114 to mark the margins of the specimen. The marker 116 defines anaperture 126 sized to accommodate sutures 118, staples, or likeconnecting means for securing the marker 116 to the specimen 114. Thesutures 118 may be any length, although longer lengths will allow themarker 116 to be moved away from the specimen 114 during radiography,thereby reducing or eliminating possible obstruction of the specimen 114caused by the image of the radiopaque marker 116. A user 130 grips (withfingers, forceps, pliers, or other means) the base 112 while securingthe marker 116 to the specimen 114. Once attached, the marker 116,because of its distinctive shape and indicia 124, identifies theorientation of the specimen 114 prior to removal from the patient'sbody. The user 130 then disconnects the marker 116 from the base 112 bybreaking the marker 116 at a frangible connection 122. The user 130 maythen mark different areas of the specimen 114 with the remaining markers120 and/or may dispose of the device 110. Because the markers 116 areradiopaque, the markers 116 will appear on a radiograph of the specimen.

[0020] Referring now to FIGS. 2A-C, the base 112, frangible connections122, and markers 116 are formed by photoetching a single piece ofradiopaque material. For ease of handling the desirably small markers,each marker 116 is joined to the base 112 at a respective connection122. The base 112 is of sufficient size to allow ease of handling themargin marking device 110, whether a user is using forceps, fingers, orother means to hold the base 112. The base 112 is circular, but thosewith ordinary skill in the pertinent art will notice that virtually anyshape could be used for the base 112 including hexagons, triangles,rods, ovals, stars and other shapes. The connection 122 is strong enoughto prevent inadvertent breakage, but weak enough to allow a user todisconnect the marker 116 from the base 112 once the marker 116 isattached to a specimen. The connection 122 can be a frangible connection(if the base and markers are constructed of a single piece of material,as shown), or can be any of numerous other types of connections thatwill allow for easy disconnection of the marker 116 from the base 112.Other such connections include, without limitation, wires, removable orbreakable pins, hooks, adhesives, or the like.

[0021] As can be seen, each marker 116 defines a distinctive shapewhich, once attached to a specimen, indicates orientation of thespecimen prior to removal. Indicia 124, also photoetched from theradiopaque material, aid in indicating orientation of each marker 116.In the illustrated embodiment, the indicia 124 are letters defined byapertures photoetched through the respective marker. Since the markers116 are formed from radiopaque material, the markers will cast an imagewhen radiographed, thus making the indicia 124 and/or distinctive shapeof the marker 116 visible. As shown, the markers 116 each indicateorientation preferably by including indicia 124 in the form of one ofthe following words: “cranial,” “caudal,” “medial,” “deep,” “lateral,”or “skin,” and each marker further defines a peripheral shape forming agraphical representation of the respective indicia.

[0022] One of ordinary skill in the pertinent art will recognize thatthe indicia 124 can be formed through processes other than photoetching.For example, indicia 124 also may be formed in the radiopaque markers116 by stamping, laser cutting, or by other means. In FIGS. 2A-C, theindicia 124 are defined by one or more apertures formed through therespective marker 116, those apertures defining the shapes of letters.Alternatively, the indicia can comprise distinctive shapes or otherforms to provide unique identifying information. One of ordinary skillin the pertinent art also will recognize that the indicia themselves maybe radiopaque. This method would allow the indicia to be mounted on orembedded in a non-radiopaque marker. In this case, indicia may beapplied to each marker by printing the indicia thereon with a radiopaqueink or other suitable material. Radiopaque indicia could also beembedded within non-radiopaque markers while the markers are beingformed (i.e., during casting, injection molding, or some other process).

[0023] It will be apparent to one of ordinary skill in the pertinent artthat the markers 116, including the indicia 124 and/or the distinctiveshapes of the markers, can define virtually any information relevant tothe marking of specimens. Additionally, the marking system indicated,while directed to breast specimens, can be utilized with obviousmodifications to mark any type of specimen, from any body part, for anypurpose. A non-exhaustive list of possible alternative indicia includethe words: “breast,” “first,” “second,” “left,” “right,” “malignant,”“base,” “testicle,” “anterior,” etc. In addition, each marker may definea respective shape forming a graphical representation of therepresentative indicia or otherwise conveying desired information. Eachmarker 116 defines an aperture 126 large enough to accommodate sutures,staples or other attachment elements as desired, which allow fastattachment of the marker 116 to a specimen.

[0024] In the currently preferred embodiment of FIGS. 2A-C, the marginmarking device 110 is approximately one inch in diameter, with eachmarker 116 defining a footprint of approximately 0.2 inches by 0.2inches. The small size of the individual markers 116 allows for accuratemarking of specimen margins and decreases the amount of specimenobstructed by the marker's image during xray. The base 112 and themarkers 116 are both approximately 0.005 inch thick, which reduces thepossibility of markers 116 impeding the required flattening of aspecimen during radiography. Those of ordinary skill in the pertinentart will note that the thickness and size of the markers 116 can varydepending on any of numerous different factors, such as the size of thespecimen to which the markers 116 will be affixed (i.e., larger markerscan be attached to larger specimens).

[0025] Those of ordinary skill in the pertinent art also will recognizethat the margin marking device 110 can be made from any of numerousdifferent materials that are currently or later become known forperforming the function of the markers described herein. While FIG. 1shows a marking device 110 made from a single piece of stainless steel,other radiopaque materials may be used, including platinum, titanium,lead, other metals or alloys, non-radiopaque materials with radiopaquecoatings, or any combination of any of the foregoing. Additionally,non-radiopaque markers may be used with radiopaque indicia fixedthereon. In addition, the markers could be made of partially radiopaque,partially radiolucent material as disclosed in U.S. patent applicationSer. No. 09/372,835, filed Aug. 12, 1999, entitled “An intermediatedensity marker and a method for using such a marker for radiographicexamination”, which is assigned to the assignee of the present inventionand is hereby expressly incorporated by reference as a part of thepresent disclosure. This material would allow the image of the marker toappear on a radiograph yet would not obstruct any underlying structureof the specimen from being visible through the image of the marker onthe radiograph.

[0026] Photoetching is the currently preferred method of making themargin marker system, since this process is relatively cost-effective,produces a precise reproduction of the original design, and produces amarking device that is burr and stress free. Photoetching also allowsfor a simple way to manufacture the entire device (base, connections,and markers) as a single piece. Other manufacturing processes such asstamping, casting, injection-molding, laser-cutting, and the likeequally may be used.

[0027] Referring to FIG. 3, a margin marking device 310 defines ahexagonal base 312. As will be appreciated by those of ordinary skill inthe pertinent art, margin marking device 310 utilizes the sameprinciples of the margin marking device 110 of FIGS. 1 and 2A-C.Accordingly, like reference numerals preceded by the numeral “3,”instead of the numeral “1,” are used to indicate like elements. Eachbase 312 is connected to plate 316 at a respective connection 322. Eachplate 316 is radiopaque and is photoetched with indicia 324 defining arespective unique orientation. Each plate 316 is connected to arespective wire 328 which is, in turn, connected to respective closedring defining an aperture. The aperture 326 of each closed ring is sizedto accommodate sutures, staples, or like connecting means, and may befabricated from any of numerous materials available in the art and thosedeveloped in the future.

[0028] The length of each wire 328 may be set as desired. Alternatively,the wire 328 may be eliminated and each closed ring may be directlyconnected to the respective plate 316. The presence of the wire 328 isparticularly useful for extremely small specimens, where little or noobstruction of the radiograph by the plate 316 would be acceptable. Inthis case, the closed ring can be fixed to a specimen, and therespective plate 316 can be moved away from the specimen during xrayprocedures, thereby eliminating possible obstruction of relevantportions of the specimen by the radiopaque plate 316. The wire 328 maybe fabricated from radiopaque, non-radiopaque material, or partiallyradiopaque, partially radiolucent. A radiopaque wire 328 would beparticularly useful, as it would be visible on a radiograph of thespecimen, thereby defining a line from the respective plate 316 to thepoint of connection on the specimen. This would allow those viewing theradiograph to pinpoint the location of a particular point of interest onthe specimen, without blocking that point with a radiopaque plate 316.

[0029]FIG. 4 shows a margin marking device 410 particularly well-suitedto known methods of plastic construction. A rod-shaped base 412 isconnected to markers 416 at frangible connections 422. Each marker 416defines unique indicia, shown typically at 424, indicative of arespective orientation. The indicia 424 may be defined by one or moreapertures formed through the respective marker 416, wherein theapertures define the shapes of letters and/or other unique identifyinginformation. Alternatively, the indicia 424 may be applied to eachmarker 416 by printing the indicia thereon with a radiopaque ink orother suitable material. An aperture 426 is present in each marker 416for attaching sutures, staples, or like attachment means. The marginmarking device 410 can be molded as one piece of plastic or othersuitable material. Each plastic marker 416 may be sufficientlyradiopaque to mark the specimen. Alternatively, a radiopaque coating maybe applied to each marker 416, or radiopaque material may be embedded orattached to the markers 416 in a manner known to those of ordinary skillin the pertinent art.

[0030] Although FIGS. 1 through 4 show margin marking devices having aplurality of markers connected to a base, one of ordinary skill in thepertinent art will recognize that the markers individually are novel intheir own right. While the small size of the markers necessitates theuse of a base to hold the markers as those markers are being fixed tospecimens, this base is not necessary for larger markers, which can bestored in a container until they are secured to a specimen. These largermarkers could be used to mark the margins of larger specimens, specimenswhere obstruction caused by the image of the marker during radiographyis less of a concern, or for markers made of partially radiopaque,partially radiolucent material. The novelty of the present invention isnot lost with an increase of marker size and the elimination of thebase, as the advantages of a marker that remains secured to a specimenand standardizes the method of marking specimens still exist.

[0031] The skilled artisan also will recognize that any or allcomponents of the margin marking device of the present disclosure(including the base and markers) could be made from many materialspresently available in the art or invented in the future. If a marker ismade from radiopaque material (or non-radiopaque material coated withradiopaque coating), indicia can be formed on the marker, either byphotoetching, stamping or other means. The markers themselves also maydefine a distinctive shape without indicia, provided the markers are ofsuch a shape as to clearly indicate a unique orientation or otherrequisite identifying information. Markers also may be completelynon-radiopaque, with radiopaque indicia printed or otherwise fixedthereon. It also will be apparent to those of ordinary skill in thepertinent art that the base and markers may be manufactured from morethan one piece of material or various combinations of materials. Aftermanufacture, the markers could be attached to the base in any ofnumerous different ways that allow for disconnection during use. Asindicated above, these points of connection between the markers and thebase may be formed by hooks, wire, pins, frangible portions, or likeconnections.

[0032] Although the invention has been described in terms of exemplaryembodiments, it is not limited thereto. Rather, the appended claimsshould be construed broadly, to include other variants and embodimentsof the invention, which may be made by those skilled in the art withoutdeparting from the scope and range of the equivalents of the inventionas defined by the appended claims.

What is claimed is:
 1. A device for margin marking of radiographyspecimens, comprising: a base for gripping during use; and a pluralityof markers detachably fixed to said base, each marker defining anaperture for attaching the marker to a specimen and indicia visible whenradiographed and indicative of orientation of the specimen.
 2. Themargin marking device set forth in claim 1, wherein each marker isfabricated from radiopaque material.
 3. The margin marking device setforth in claim 2, wherein a plurality of the markers each comprises aperipheral surface defining a unique shape.
 4. The margin marking deviceset forth in claim 1, wherein each marker defines a unique orientationrelative to the other markers.
 5. The margin marking device set forth inclaim 1, wherein each of the markers defines a unique orientation,including (i) a first marker defining a cranial orientation; (ii) asecond marker defining a caudal orientation; (iii) a third markerdefining a medial orientation; (iv) a fourth marker defining a deeporientation; (v) a fifth marker defining a lateral orientation; and (vi)a sixth marker defining a skin orientation.
 6. The margin marking deviceset forth in claim 1, wherein each of the markers comprises indiciadefined by at least one aperture.
 7. The margin marking device set forthin claim 6, wherein each indicia includes characters indicative of aunique orientation.
 8. The margin marking device set forth in claim 7,wherein each of the markers comprises a peripheral surface defining aunique shape and indicative of orientation.
 9. A margin marker forradiography specimens comprising: an aperture for attaching the markerto a specimen; and indicia visible when radiographed and indicative oforientation of the specimen.
 10. The margin marker set forth in claim 9,wherein the marker is fabricated from radiopaque material.
 11. Themargin marker set forth in claim 10, wherein each of the markerscomprises a peripheral surface defining a unique shape indicative oforientation.
 12. The margin marker set forth in claim 9, wherein themarker is radiopaque and defines an orientation consisting of at leastone of the following: cranial, caudal, medial, deep, lateral, and skin.13. The margin marker set forth in claim 12, wherein each of the markerscomprise indicia defined by at least one aperture.
 14. The margin markerset forth in claim 13, wherein each indicia includes charactersindicative of a unique orientation.
 15. A method of marking the marginsof a radiography specimen comprising the steps of: providing a marginmarking device having a base with at least one marker detachably fixedto the base, and wherein the at least one marker defines an aperture;gripping the base and holding the marker against or adjacent to arespective marginal portion of a specimen; securing the marker to themarginal portion of the specimen through the aperture and into thespecimen; and disconnecting the marker from the base and leaving themarker secured to the marginal portion of the specimen to indicate theorientation of the specimen.
 16. The method of marking set forth inclaim 15, wherein the securing element is at least one of a suture or astaple.
 17. A method of marking the margins of a radiography specimencomprising the steps of: providing a marker having indicia visible on aradiograph and indicative of orientation; securing the marker to amarginal portion of a specimen corresponding to the respective indicia;radiographing the specimen and marker attached thereto; displaying onthe radiograph the indicia to thereby show the orientation of thespecimen.
 18. The method of marking set forth in claim 17, wherein thesecuring element is at least one of a suture and a staple.
 19. Themethod of marking set forth in claim 18, further comprising at least oneof the following steps: (i) securing a marker with indicia indicative ofcaudal orientation to the caudal margin of the specimen; (ii) securing amarker with indicia indicative of medial orientation to the medialmargin of the specimen; (iii) securing a marker with indicia indicativeof deep orientation to the deep margin of the specimen; (iv) securing amarker with indicia indicative of lateral orientation to the lateralmargin of the specimen; (v) securing a marker with indicia indicative ofskin orientation to the skin margin of the specimen; and (vi) securing amarker with indicia indicative of cranial orientation to the cranialmargin of the specimen.
 20. A device for margin marking of radiographyspecimens, comprising: first means for marking a marginal portion of thespecimen; second means for supporting the first means and for grippingduring use; third means for visually indicating the orientation of thespecimen on a radiograph; fourth means for detachably connecting thefirst means to the second means; and fifth means for securing the markerto the marginal portion of the specimen.
 21. The device for marginmarking set forth in claim 20, wherein the first means is defined by amarker formed by a material that is at least partially radiopaque. 22.The device for margin marking set forth in claim 20, wherein the secondmeans is defined by a base including at least one surface for grippingduring use.
 23. The device for margin marking set forth in claim 20,wherein the third means is defined by indicia.
 24. The device for marginmarking set forth in claim 23, wherein the indicia is defined bycharacters.
 25. The device for margin marking set forth in claim 23,wherein the indicia is defined by a peripheral shape.
 26. The device formargin marking set forth in claim 23, wherein the indicia is defined byat least one aperture.
 27. The device for margin marking set forth inclaim 20, wherein the fourth means is defined by at least one of afrangible portion.
 28. The device for margin marking set forth in claim20, wherein the fifth means is defined by at least one aperture forreceiving at least one of a suture and a staple.
 29. The device formargin marking set forth in claim 28, wherein the suture is sufficientlylong to allow the first means to lie flat during radiographicprocedures.
 30. The device for margin marking set forth in claim 20,wherein the first means and second means are approximately planar.